Evidence map›Paper›PMID 35164840›Full record

Trial reportTrials2022

Intranasal dexamethasone: a new clinical trial for the control of inflammation and neuroinflammation in COVID-19 patients.

Graciela Cárdenas, María Chávez-Canales, Ana María Espinosa, Antonio Jordán-Ríos, Daniel Anica Malagon, Manlio Fabio Márquez Murillo, Laura Victoria Torres Araujo, Ricardo Leopoldo Barajas Campos, Rosa María Wong-Chew, Luis Esteban Ramirez González and 45 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04513184 (Randomized Clinical Trial of Intranasal Dexamethasone as an Adjuvant in Patients With COVID-19), which is not on this map. Cited by 7 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed, 1 pooled it
1.2field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04513184 phase2completednot on this map

Randomized Clinical Trial of Intranasal Dexamethasone as an Adjuvant in Patients With COVID-19

TypeinterventionalSponsorEdda Sciutto CondeRan2021 to 2021Enrolled66ConditionsCovid19ArmsIV Dexamethasone, Nasal Dexamethasone
3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Review
  4. Observational
  5. Review
  6. Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

55 authors at 10 institutions in 2 countries.

Graciela CárdenasInstituto Nacional de Neurología y Neurocirugía (INNN), Av. Insurgentes Sur 3877, La Fama, Tlalpan, 14269, Mexico, Mexico.
María Chávez-CanalesUnidad de Investigación UNAM-INC, Instituto Nacional de Cardiología Ignacio Chávez and Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Juan Badiano No. 1, Col. Sección XVI, Tlalpan, 14080, Mexico, Mexico.
Ana María EspinosaClinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Dr. Balmis 148, Doctores, Cuauhtémoc, 06720, Mexico, Mexico.
Antonio Jordán-RíosInstituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Belisario Domínguez Secc 16, Tlalpan, 14080 Mexico City, CDMX, Mexico.
Daniel Anica MalagonClinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Dr. Balmis 148, Doctores, Cuauhtémoc, 06720, Mexico, Mexico.
Manlio Fabio Márquez MurilloInstituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Belisario Domínguez Secc 16, Tlalpan, 14080 Mexico City, CDMX, Mexico.
Laura Victoria Torres AraujoInstituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Belisario Domínguez Secc 16, Tlalpan, 14080 Mexico City, CDMX, Mexico.
Ricardo Leopoldo Barajas CamposInstituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Belisario Domínguez Secc 16, Tlalpan, 14080 Mexico City, CDMX, Mexico.
Rosa María Wong-ChewFacultad de Medicina, Universidad Nacional Autónoma de México, 04510, Mexico, Mexico.
Luis Esteban Ramirez GonzálezUnidad Temporal COVID-19, Centro Citibanamex, Avenida del Conscripto 311, Lomas de Sotelo, 11200 Miguel Hidalgo, CDMX, Mexico.
Karent Ibet CresencioUnidad Temporal COVID-19, Centro Citibanamex, Avenida del Conscripto 311, Lomas de Sotelo, 11200 Miguel Hidalgo, CDMX, Mexico.
Enrique García VelázquezUnidad Temporal COVID-19, Centro Citibanamex, Avenida del Conscripto 311, Lomas de Sotelo, 11200 Miguel Hidalgo, CDMX, Mexico.
Mariana Rodriguez de la CerdaUnidad Temporal COVID-19, Centro Citibanamex, Avenida del Conscripto 311, Lomas de Sotelo, 11200 Miguel Hidalgo, CDMX, Mexico.
Yoana LeyvaInstituto Nacional de Cardiología Ignacio Chávez, Juan Badiano 1, Belisario Domínguez Secc 16, Tlalpan, 14080 Mexico City, CDMX, Mexico.
Joselin Hernández-RuizClinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Dr. Balmis 148, Doctores, Cuauhtémoc, 06720, Mexico, Mexico.
María Luisa Hernández-MedelClinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Dr. Balmis 148, Doctores, Cuauhtémoc, 06720, Mexico, Mexico.
Mireya León-HernándezClinical Pharmacology Unit, Hospital General de México Dr. Eduardo Liceaga, Dr. Balmis 148, Doctores, Cuauhtémoc, 06720, Mexico, Mexico.
Karen Medina QueroHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Anahí Sánchez MonciváisHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Sergio Hernández DíazHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Ignacia Rosalia Zeron MartínezHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Adriana Martínez-CuazitlHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Iván Noé Martínez SalazarHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Eduardo Beltrán SarmientoHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Aldo Figueroa PeñaHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Patricia Saraí HernándezHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Rafel Ignacio Aguilar ReynosoHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Daniela Murillo ReyesHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Luis Rodrigo Del Río AmbrizHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Rogelio Antonio Alfaro BonillaHospital Militar, Secretaría de la Defensa Nacional, Periférico Blvrd Manuel Ávila Camacho s/n, Militar, Miguel Hidalgo, 11200 Mexico City, CDMX, Mexico.
Jocelyn CruzInstituto Nacional de Neurología y Neurocirugía (INNN), Av. Insurgentes Sur 3877, La Fama, Tlalpan, 14269, Mexico, Mexico.
Leonor HuertaDepartamento de Inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Circuito escolar s/n, 04510, Mexico, Mexico.
Nora Alma FierroDepartamento de Inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Circuito escolar s/n, 04510, Mexico, Mexico.
Marisela HernándezDepartamento de Inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Circuito escolar s/n, 04510, Mexico, Mexico.
Mayra Pérez-TapiaUnidad de Desarrollo e Investigación en Bioprocesos, Escuela Nacional de Ciencias Biológicas del Instituto Politécnico Nacional, Prolongación de Carpio y Plan de Ayala S/N, Col. Casco de Santo Tomas, Del. Miguel Hidalgo, 11340, Mexico, Mexico.
Gabriela MenesesInstituto de Diagnóstico y Referencia Epidemiológicos Dr. Manuel Martínez Báez, Francisco de Miranda 177, Lomas de Plateros, Álvaro Obregón, 01480, Mexico, Mexico.
Erick Espíndola-ArriagaDepartamento de Inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Circuito escolar s/n, 04510, Mexico, Mexico.
Gabriela RosasFacultad de Medicina, Universidad Autónoma del Estado de Morelos, Avenida Universidad No. 1001, Chamilpa, 62209, Cuernavaca, Morelos, Mexico.
Alberto ChinneyUnidad Temporal COVID-19, Centro Citibanamex, Avenida del Conscripto 311, Lomas de Sotelo, 11200 Miguel Hidalgo, CDMX, Mexico.
Sergio Rosales MendozaUniversidad Autónoma de San Luis Potosí, Álvaro Obregón 64, Col. Centro, C.P. 78000, San Luis Potosí, S.L.P, Mexico.
Juan Alberto Hernández-AcevesDepartamento de Inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Circuito escolar s/n, 04510, Mexico, Mexico.
Jaquelynne Cervantes-TorresDepartamento de Inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Circuito escolar s/n, 04510, Mexico, Mexico.
Anai Fuentes RodríguezLaboratorio Nacional de Citometría de Flujo, Instituto de Investigaciones Biomédicas, UNAM, 04510, Mexico, Mexico.
Roxana Olguin AlorLaboratorio Nacional de Citometría de Flujo, Instituto de Investigaciones Biomédicas, UNAM, 04510, Mexico, Mexico.
Sandra Ortega FranciscoLaboratorio Nacional de Citometría de Flujo, Instituto de Investigaciones Biomédicas, UNAM, 04510, Mexico, Mexico.
Evelyn Alvarez SalazarLaboratorio Nacional de Citometría de Flujo, Instituto de Investigaciones Biomédicas, UNAM, 04510, Mexico, Mexico.
Hugo BesedovskyInstitute of Physiology and Pathophysiology, Emil-Mannkopff-Straße 2 u, 35037, Marburg, Germany.
Marta C RomanoDepartamento de Fisiología, Biofísica y Neurociencias, Centro de Investigación y Estudios Avanzados del Instituto Politécnico Nacional, Av. Instituto Politécnico Nacional 2508, San Pedro Zacatenco, Gustavo A. Madero, 07360, Mexico, Mexico.
Raúl J BobesDepartamento de Inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Circuito escolar s/n, 04510, Mexico, Mexico.
Helgi JungFacultad de Química, Universidad Nacional Autónoma de México, 04510, Mexico, Mexico.
Gloria SoldevilaLaboratorio Nacional de Citometría de Flujo, Instituto de Investigaciones Biomédicas, UNAM, 04510, Mexico, Mexico.
Juan López-AlvarengaSchool of Medicine, University of Texas Rio Grande Valley - UTRGV, 1201 W University Dr, Edinburg, TX, 78539, USA.
Gladis FragosoDepartamento de Inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Circuito escolar s/n, 04510, Mexico, Mexico.
Juan Pedro LacletteDepartamento de Inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Circuito escolar s/n, 04510, Mexico, Mexico.
Edda SciuttoDepartamento de Inmunología, Instituto de Investigaciones Biomédicas, Universidad Nacional Autónoma de México, Circuito escolar s/n, 04510, Mexico, Mexico. edda@unam.mx.ORCID http://orcid.org/0000-0001-5608-5355
Universidad Nacional Autónoma de México · MXSecretaría de la Defensa NacionalInstituto Nacional de Cardiología · MXHospital General de México · MXInstituto Nacional de Neurología y Neurocirugía · MXInstituto Politécnico Nacional · MXAutonomous University of San Luis Potosí · MXSecretaria de Salud · MXThe University of Texas Rio Grande Valley · USUniversidad Autónoma del Estado de Morelos · MX

Funding

dgapa-unam, papiit IN201020mexican agency for international development cooperation 318.01
6 · The paper itself

Abstract

backgroundBy end December of 2021, COVID-19 has infected around 276 million individuals and caused over 5 million deaths worldwide. Infection results in dysregulated systemic inflammation, multi-organ dysfunction, and critical illness. Cells of the central nervous system are also affected, triggering an uncontrolled neuroinflammatory response. Low doses of glucocorticoids, administered orally or intravenously, reduce mortality among moderate and severe COVID-19 patients. However, low doses administered by these routes do not reach therapeutic levels in the CNS. In contrast, intranasally administered dexamethasone can result in therapeutic doses in the CNS even at low doses.

methodsThis is an approved open-label, multicenter, randomized controlled trial to compare the effectiveness of intranasal versus intravenous dexamethasone administered in low doses to moderate and severe COVID-19 adult patients. The protocol is conducted in five health institutions in Mexico City. A total of 120 patients will be randomized into two groups (intravenous vs. intranasal) at a 1:1 ratio. Both groups will be treated with the corresponding dexamethasone scheme for 10 days. The primary outcome of the study will be clinical improvement, defined as a statistically significant reduction in the NEWS-2 score of patients with intranasal versus intravenous dexamethasone administration. The secondary outcome will be the reduction in mortality during hospitalization.

conclusionsThis protocol is currently in progress to improve the efficacy of the standard therapeutic dexamethasone regimen for moderate and severe COVID-19 patients.

trial registrationClinicalTrials.gov NCT04513184 . Registered November 12, 2020. Approved by La Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) with identification number DI/20/407/04/36. People are currently being recruited.

Indexed as

COVID-19 Drug TreatmentDexamethasoneHumansInflammationNeuroinflammatory DiseasesSARS-CoV-2Treatment OutcomeDexamethasoneCOVID-19DexamethasoneInflammationIntranasal administrationNeuroinflammation

Identifiers

PMID35164840
PMCPMC8845269
OpenAlexW4226060358

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.